Overview
Cefixime, an antibiotic, is a third-generation cephalosporin like ceftriaxone and cefotaxime. Cefixime is highly stable in the presence of beta-lactamase enzymes. As a result, many organisms resistant to penicillins and some cephalosporins due to the presence of beta-lactamases, may be susceptible to cefixime. The antibacterial effect of cefixime results from inhibition of mucopeptide synthesis in the bacterial cell wall.
Background
Cefixime, an antibiotic, is a third-generation cephalosporin like ceftriaxone and cefotaxime. Cefixime is highly stable in the presence of beta-lactamase enzymes. As a result, many organisms resistant to penicillins and some cephalosporins due to the presence of beta-lactamases, may be susceptible to cefixime. The antibacterial effect of cefixime results from inhibition of mucopeptide synthesis in the bacterial cell wall.
Indication
For use in the treatment of the following infections when caused by susceptible strains of the designated microorganisms: (1) uncomplicated urinary tract infections caused by Escherichia coli and Proteus mirabilis, (2) otitis media caused by Haemophilus influenzae (beta-lactamase positive and negative strains), Moraxella catarrhalis (most of which are beta-lactamase positive), and S. pyogenes, (3) pharyngitis and tonsillitis caused by S. pyogenes, (4) acute bronchitis and acute exacerbations of chronic bronchitis caused by Streptococcus pneumoniae and Haemophilus influenzae (beta-lactamase positive and negative strains), and (5) uncomplicated gonorrhea (cervical/urethral) caused by Neisseria gonorrhoeae (penicillinase- and non-penicillinase-producing strains).
Associated Conditions
- Acute Exacerbation of Chronic Bronchitis caused by Streptococcus Pneumoniae
- Acute Exacerbations of Chronic Bronchitis caused by Haemophilus Influenzae
- Bacterial Sinusitis
- Community Acquired Pneumonia (CAP)
- Gonorrhea of anus
- Lyme Disease
- Salmonella Infections
- Shigella Infection
- Streptococcal Pharyngitis
- Tonsillitis streptococcal
- Uncomplicated Urinary Tract Infections
- Bacterial otitis media
- Bacterial rhinosinusitis
- Disease caused by Salmonella typhi
- Uncomplicated Gonorrhea
Clinical Trials
Title | Posted | Study ID | Phase | Status | Sponsor |
|---|---|---|---|---|---|
2025/04/02 | Phase 4 | Terminated | Bulovka Hospital | ||
2023/10/19 | Phase 4 | Completed | Bulovka Hospital | ||
2022/03/24 | Phase 2 | Recruiting | |||
2022/01/31 | Phase 2 | Completed | Haiphong University of Medicine and Pharmacy | ||
2021/08/30 | Not Applicable | UNKNOWN | |||
2021/07/29 | Not Applicable | Completed | |||
2021/07/12 | Phase 3 | Recruiting | |||
2020/04/16 | Phase 4 | Recruiting | |||
2019/05/31 | Phase 3 | UNKNOWN | Post Graduate Institute of Medical Education and Research, Chandigarh | ||
2019/02/15 | Phase 1 | Completed |
FDA Drug Approvals
Approved Product | Manufacturer | NDC Code | Route | Strength | Effective Date |
|---|---|---|---|---|---|
| Lupin Pharmaceuticals, Inc. | 27437-206 | ORAL | 200 mg in 5 mL | 12/15/2023 | |
| Lupin Pharmaceuticals, Inc. | 27437-201 | ORAL | 400 mg in 1 1 | 12/15/2023 | |
| Lupin Pharmaceuticals, Inc. | 27437-208 | ORAL | 400 mg in 1 1 | 12/15/2023 | |
| Lupin Pharmaceuticals, Inc. | 68180-416 | ORAL | 400 mg in 1 1 | 1/10/2023 | |
| Aurobindo Pharma Limited | 65862-752 | ORAL | 200 mg in 5 mL | 2/14/2024 | |
| Lupin Pharmaceuticals, Inc. | 68180-423 | ORAL | 400 mg in 1 1 | 1/10/2023 | |
| Lupin Pharmaceuticals, Inc. | 68180-405 | ORAL | 100 mg in 5 mL | 1/10/2023 | |
| Aurobindo Pharma Limited | 65862-751 | ORAL | 100 mg in 5 mL | 2/14/2024 | |
| Ascend Laboratories, LLC | 67877-584 | ORAL | 400 mg in 1 1 | 11/30/2021 | |
| Lupin Pharmaceuticals, Inc. | 27437-205 | ORAL | 200 mg in 1 1 | 12/15/2023 |
EMA Drug Approvals
Approved Product | Authorization Holder | Status | Issued Date |
|---|---|---|---|
| No EMA approvals found for this drug. | |||
HSA Drug Approvals
Approved Product | Manufacturer | Approval Number | Dosage Form | Strength | Approval Date |
|---|---|---|---|---|---|
| No HSA approvals found for this drug. | |||||
NMPA Drug Approvals
Approved Product | Company | Approval Number | Drug Type | Dosage Form | Approval Date |
|---|---|---|---|---|---|
| Cefixime for Suspension | 国药准字H20061203 | 化学药品 | 干混悬剂 | 2/14/2020 | |
| Cefixime for Suspension | 国药准字H20041545 | 化学药品 | 口服混悬剂 | 7/28/2020 | |
| Cefixime for Suspension | 国药准字H20041779 | 化学药品 | 干混悬剂 | 10/23/2020 | |
| Cefixime for Suspension | 国药准字H20052077 | 化学药品 | 口服混悬剂 | 4/13/2020 | |
| Cefixime for Suspension | 国药准字H20080110 | 化学药品 | 口服混悬剂 | 1/6/2023 | |
| Cefixime for Suspension | 国药准字H20040810 | 化学药品 | 干混悬剂 | 9/12/2019 | |
| Cefixime for Suspension | 国药准字H20060266 | 化学药品 | 干混悬剂 | 4/24/2021 | |
| Cefixime for Suspension | 国药准字H20061202 | 化学药品 | 干混悬剂 | 2/10/2020 | |
| Cefixime for Suspension | 国药准字H20041122 | 化学药品 | 干混悬剂 | 2/14/2020 | |
| Cefixime for Suspension | 国药准字H20041780 | 化学药品 | 干混悬剂 | 10/23/2020 |
PPB Drug Approvals
Approved Product | Registration No. | Company | Licence No. | Strength | Registration Date |
|---|---|---|---|---|---|
| No PPB approvals found for this drug. | |||||
TGA Drug Approvals
Approved Product | ARTG ID | Sponsor | Registration Type | Status | Registration Date |
|---|---|---|---|---|---|
| No TGA approvals found for this drug. | |||||